a. Field of the Invention
The present invention pertains generally to devices and methods for puncturing tissue within the body. More particularly, the invention is directed to devices and methods for puncturing the interatrial septum and/or pericardial sac to facilitate atrial and/or epicardial ablation.
b. Background Art
The traditional method for gaining access to the left atrium is to puncture the interatrial septum at the location of the fossa ovalis. Access to the left atrium is needed for a variety of therapeutic medical procedures, for example left atrial radiofrequency catheter ablation. Nevertheless, transseptal puncture has numerous potential complications. For instance, advancing the needle beyond the interatrial septum may result in inadvertent puncture of heart structures such as the left atrial free wall. Moreover, improperly puncturing a site other than the fossa ovalis—a structure notoriously difficult to locate—may lead to certain surgical complications. Additionally, reliably verifying that puncture was successful may be complicated by a lack of left atrial access post-puncture.
Many current transseptal needle devices and assemblies do not address these concerns. For instance, some transseptal needle devices feature a needle which punctures tissue in a substantially straight orientation and cannot be manipulated to puncture tissue at an angle. In essence, a physician using such a device is puncturing the interatrial septum with little to no information regarding the precise location of heart structures beyond the interatrial septum. Moreover, the physician is uniformly using the same puncturing angle from procedure to procedure regardless of the positioning of the transseptal needle device relative to the interatrial septum.
Accordingly, there is a growing need for tissue puncture assemblies that are capable of puncturing a tissue at an oblique angle. Moreover, there is a growing need for tissue puncture assemblies that may provide more precise information regarding the location of key structures such as the left atrial free wall and the fossa ovalis. Furthermore, there is a growing need for transseptal needle devices capable of maintaining access to the left atrium post-puncture.